Jesus Carrillo Email and Phone Number

•Lead risk management, verification, and validation activities •Manage Engineering Change Controls•Provide CSA/CSV Validation Support•Assist in executing, reviewing and approving of Validation/Qualification Documentation (IQ/OQ/PQ).•Ensure systems are fully implemented and integrated with quality management systems, at the site, and global level functions. •Ensure alignment of processes, procedures, and methods across multiple organizations (internal and external). •Author and revise SOPs and other LCD. •Provide guidance on revising validation documents and protocols. Worked for multiple client(s): Panthera Biosolutions, Alcon, Novartis Pharmaceuticals, in Fort Worth Texas for different projects that include validating projects such as: -AHU for Clean Rooms-EMPQ for Automated Filling Lines -Building Automation System-Cleanroom DP Monitoring-Warehouse Temperature Monitoring-Particle Monitoring Systems-Lyophilizer PQ-Integated Isolator IQ/OQ/PQ-Mechanical/Plumbing Cx -WFI/Clean Steam Utilities-RO/DI system-Process Air & Nitrogen-Plumbing Special Systems (Compressed Air, Vacuum System, Specialty gas)

Client: Novartis Pharmaceuticals, Fort Worth TexasCreate and update Commissioning Plan as project progresses through its various phases.Schedule & conduct commissioning coordination meetings.Develop Commissioning, Qualification & Validation Protocols as needed.Witness equipment and systems start-up and testing. Conduct verification tests.Prepare Final Commissioning Package.

•Prepared annual operating budget of around 600,000 USD.•Developed and sustained positive business relationships with tenants, companies, and suppliers.•Created Maintenance & Operations Plans for all building systems. •Managed Engineering and Maintenance Contractors. •Investigated and resolved escalated or complex tenant and customer complaints.•Helped startup companies with new product development processes which will includes design assurance, risk analysis, risk management, regulatory strategy, product redesign and enhancements, as well as manufacturing transfer.• Helped a pharma startup company to put together ANDA, set up facility & equipment, and process validation activities. • Helped a medical device startup with regulatory and product development strategy.• Helped start-up BIO El Paso Juarez Association. •Partnered with legal to process any necessary agreements.•Participated as Owner representative of a 30,000 sq.-ft VA Mental Health Clinic facility project •Worked closely with project delivery team assuring essential project performance requirements, goals for project quality, efficiency, and functionality.•Created operating model for onboarding new lab tenants, including facilities / equipment / EH&S / security management, and off-boarding procedures.•Developed and implemented a facility wide QMS and CMMS.•Reviewed technical documents & drawings PID using (CAD/CAM). •Responsible for complete on-time and on-budget construction of Cardwell Collaborative, a 60,000 sq.-ft $30M USD private biomedical research and tech commercialization facility.•Participated during lab equipment selection, procurement, and qualification. •Helped adjust Lab Air Balancing Supply & Exhaust.•Performed equipment IQ/OQ of the following wet lab equipment (Autoclave, Freezers, Incubators, water systems)•Developed, revised, and performed functional checklists & tests.•Helped Performed SAT for all equipment.

•Completed SRS & redesigned calibration and maintenance internal process for three sites: Chihuahua, Mexicali and Torreon. •Collected the information of 245 tools, equipment and assets.•Completed user testing and uploaded it to IBM Maximo ERP for compliance.

• Use computer models of cardiac electrical activity to evaluate diagnostic and therapeutic approaches. • Worked with one of the top researchers in the field, PhD Vincent Jaquemet. • Used Matlab programming and Linux OS to interpret data.•Made possible thanks to the MITACS Globalink Research Internship Award.

• Managed healthcare technology by corrective and preventive maintenance.• Provided technical support to end-users on medical and clinical equipment.• Managed contract technicians performing maintenance and service calls for medical equipment• Main duties involved inspection, maintenance, reparation and calibration of bio-medical equipment.

• Learned to solve problems in a research oriented environment.• Provided assistance to researchers. • Coordinated the participation of 8 posters in a Symposium, two of them runner-up.

• Provided support to product documentation, completed the digital conversion of physical files. • Managed large databases, provided support by reviewing BOM’s in SAP during migration. • During my stay, the documentation department surpassed the annual audit.